Maurizio Maccato

IMPORTANCE: Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine could prevent infant pertussis. OBJECTIVE: To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine. DESIGN, SETTING, AND PARTICIPANTS: Phase 1-2, randomized, double-blind, placebo-controlled, clinical trial conducted from 2008 to 2012. Forty-eight pregnant women aged 18 to 45 years received Tdap (n = 33) or placebo (n = 15) at 30 to 32 weeks' gestation, with crossover immunization postpartum. INTERVENTIONS: Tdap vaccination at 30 to 32 weeks' gestation or postpartum. MAIN OUTCOMES AND MEASURES: Primary outcomes were maternal and infant adverse events, pertussis illness, and infant growth and development until age 13 months. Secondary outcomes were antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo, at delivery and 2 months' postpartum, and in infants at birth, at 2 months, and after the third and fourth doses of DTaP. RESULTS: No Tdap-associated serious adverse events occurred in women or infants. Injection site reactions after Tdap immunization were reported in 26 (78.8% [95% CI, 61.1%-91.0%]) and 12 (80% [95% CI, 51.9%-95.7%]) pregnant and postpartum women, respectively (P > .99). Systemic symptoms were reported in 12 (36.4% [ 95% CI, 20.4%-54.9%]) and 11 (73.3% [95% CI, 44.9%-92.2%]) pregnant and postpartum women, respectively (P = .03). Growth and development were similar in both infant groups. No cases of pertussis occurred. Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum (eg, pertussis toxin antibodies: 51.0 EU/mL [95% CI, 37.1-70.1] and 9.1 EU/mL [95% CI, 4.6-17.8], respectively; P < .001) and in their infants at birth (68.8 EU/mL [95% CI, 52.1-90.8] and 14.0 EU/mL [95% CI, 7.3-26.9], respectively; P < .001) and at age 2 months (20.6 EU/mL [95% CI, 14.4-29.6] and 5.3 EU/mL [95% CI, 3.0-9.4], respectively; P < .001). Antibody responses in infants born to women receiving Tdap during pregnancy were not different following the fourth dose of DTaP. CONCLUSIONS AND RELEVANCE: This preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants. For secondary outcomes, maternal immunization with Tdap resulted in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00707148.

Wound infections are a common surgical complication, often requiring a prolonged hospital stay and leading to increased costs. Over a one-year period, 2,431 patients were followed after cesarean delivery with prompt evaluation and culture of all suspicious wounds. Seventy subjects (2.8%) developed confirmed wound infection, and 42 (1.7%) developed noninfected open surgical wounds. Seven (0.3%) fascial dehiscences were diagnosed, requiring surgical repair. Forty of 63 (64%) infected wounds had positive bacterial cultures, with Staphylococcus epidermidis (29%), Enterococcus faecalis (17%), Staphylococcus aureus (17%), Escherichia coli (11%) and Proteus mirabilis (10%) the most frequent isolates. Only 7 of 42 (17%) noninfected wounds had positive cultures, with only S aureus, S epidermidis and Corynebacterium species isolated. Ninety-five percent of the noninfected wounds had blood or serous collections present. Rupture of membranes lasting longer than six hours, emergency cesarean delivery and morbid obesity were associated with a statistically increased likelihood of the development of infected wounds. Emergency cesarean delivery and morbid obesity, but not prolonged rupture of membranes, were associated with an increased likelihood of the development of noninfected wounds. Therefore, it appears that at least two mechanisms are responsible for the development of postcesarean open wounds: (1) increased amniotic fluid and wound colonization due to prolonged rupture of membranes, resulting in a wound infection containing one or more bacterial species derived from the cervicovaginal flora, and (2) increased exogenous bacterial contamination and flora consistent with skin species or breaks in sterile technique, often accompanying difficult or emergency surgery.

OBJECTIVE: To determine the microbiology of wound morbidity following cesarean deliveries. METHODS: Nine hundred thirty-nine wounds in post-cesarean patients were followed prospectively. Aspirates from the abdominal incision were collected if the wounds developed erythema, induration, or pain and had demonstrable fluid collection noted on ultrasound. Cultures were also obtained of wound exudates when there was spontaneous separation of the skin. Gram stains were performed concomitantly with culture. RESULTS: The cumulative incidence of post-cesarean wound morbidity between September 1990 and June 1991 was 6.9% (65 of 939), and the rate of culture-positive wounds was 72% (47 of 65). Ureaplasma urealyticum was the most frequent isolate at a rate of 62% (29 of 47), followed by coagulase-negative staphylococci at 32% (15 of 47) and Enterococcus faecalis at 28% (13 of 47). Gram stains of the exudates obtained were used to predict microbiologic results. Organisms present on Gram stain yielded a sensitivity of 0.55, specificity of 1.0, positive predictive value of 1.0, and negative predictive value of 0.71 when used to predict positive culture results for bacterial wound infection other than with genital mycoplasmas. White blood cell counts greater than ten per 400x high-power fields yielded a sensitivity of 0.83, specificity of 0.72, positive predictive value of 0.89, and negative predictive value of 0.62 when used to predict wound infection including genital mycoplasmas. CONCLUSIONS: Genital mycoplasmas are the most prevalent bacterium in post-cesarean wound infections in this population. If genital mycoplasmas are pathogenic in this setting, then the Gram stain may be useful in predicting wound microbiology. More research is needed on the pathogenic role of genital mycoplasmas in wound infections.